Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1377197959
Device Listing 1377197959
Listing Summary
#
Listing key
1377197959
Premarket submission
K223275
Device
CELLO II Balloon Guide Catheter
Applicant
Fuji Systems Corporation
Product code
QJP
Decision date
2022-12-09
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
348704
FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant
5
N
2026-01-01
1-23 Tsukinoiri, Kayane Shirakawa Fukushima JP 961-0004
21140
3000308637
3000308637
FUJI SYSTEMS CORPORATION, Shirakawa Plant
1
N
2026-01-01
Shirakawa Plant 200-2 Aza-Ohira, Odakura, Nishigo Nishi Shirakawa Gun Fukushima JP 961-8061